Events

Safety Alert for ARCHITECT FREE T4 REAGENTS Technical Name: FREE THYROXIN ANVISA Registration Number: 10055311070 Hazard Class: II Affected Model: Not applicable Serial Numbers Affected: 65349UI00; 65349UI01; 68194UI00; 68194UI01; 68196UI00; 68196UI01; 71292UI00; 71292UI01; 71374UI00; 71374UI01; 5415UI00; 68241UI01; 70273UI01; 71339UI00; 73200UI01; 74137UI00; 65415UI01; 68241UI00; 70273UI00; 71339UI01; 73200UI00; 74137UI01.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil; Abbott Ireland Diagnostics Division.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2298
  • Date
    2017-05-22
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    Results from patient samples between 5.00 ng / dL and 6.00 ng / dL should be reported as> 5.00 ng / dL. Review this release with your laboratory manager and discuss the potential impact on your laboratory's specific procedures, such as internal ranges. If you have forwarded the product listed above to other laboratories, please inform them of this Product Fix and provide a copy of this notice. Keep this notice in your lab files. #### Update of the field action: UPDATED ON 09/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    Change in the range of the architect free t4 assay, list numbers 7k65-29, 7k65-34 and 7k65-39. recent data generated by abbott have determined that the measurement range is from 0.40 ng / dl to 5.00 ng / dl. a measurement range is defined as the range of values ​​in ng / dl that meet acceptable performance limits for inaccuracy and linearity. the current measurement range for the list numbers 7k65-29, 7k65-34 and 7k65-39 is from 0.40 ng / dl to 6.00 ng / dl. a new ft4 test file and updated usage instructions will be created to reflect the new measurement range from 0.40 ng / dl to 5.00 ng / dl for use with the list numbers 7k65-29, 7k65-34 and 7k65-39.
  • Action
    Field Action Code FA28APR2017 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

ARCHITECT FREE T4 REAGENTS Technical Name: FREE THYROXIN ANVISA Registration Number: 10055311070 ...

Manufacturer

Abbott Laboratórios do Brasil; Abbott Ireland Diagnostics Division
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA